The Department of Health and Human Services (HHS) published a request for information (RFI) in the Federal Register on January 30, 2026, seeking public input on adopting technical standards and certification criteria for diagnostic imaging in health information technology (IT). Issued by the Assistant Secretary for Technology Policy (ASTP) and the Office of the National Coordinator for Health Information Technology (ONC), the RFI targets improvements in accessing, exchanging, and using diagnostic images such as radiographs and MRIs. Comments are due by March 16, 2026, and will guide potential future rulemaking. This development addresses longstanding challenges in health care, where images are often siloed in systems like picture archiving and communication systems (PACS), leading to reliance on physical media like CDs and DVDs. By exploring standards-based solutions, the RFI could pave the way for better patient outcomes, reduced costs from duplicative tests, and more efficient care coordination.
Purpose and Current Challenges
The RFI highlights the critical role of diagnostic images in treatment decisions across various health care settings. As defined in the document, these images include those produced by light, radiation, sound waves, or magnetic resonance. They are typically stored outside electronic health records (EHRs) in systems like PACS or vendor neutral archives (VNAs). While providers within the same organization can access them easily, external providers often face barriers due to proprietary formats, limited access to full-resolution files, or refusals to transmit images electronically. Patients bear the burden, carrying physical media or printed reports, which can compromise image quality and delay care.
HHS notes that enhanced access could improve outcomes and cut costs by minimizing unnecessary imaging. For instance, the RFI references how patients and caregivers are frequently left with outdated methods, even when electronic capabilities exist. This situation persists despite technical feasibility, driven by factors like proprietary vendor formats and organizational policies. The document cites examples where external providers receive only low-resolution images or encapsulated PDFs via web viewers, rather than full Digital Imaging and Communications in Medicine (DICOM) files.
Regulatory Background
The RFI builds on a history of ONC efforts to integrate imaging into health IT certification. In 2012, a proposed rule for the 2014 Edition of certification criteria considered but did not adopt the DICOM standard for an 'imaging' criterion, as detailed in the Federal Register (77 FR 13832). The final rule (77 FR 54163) adopted a simpler 'image results' criterion to support Medicare and Medicaid EHR Incentive Programs, allowing links to images without mandating standards. It also removed a requirement for images in the 'view, download, and transmit' (VDT) criterion due to complexity concerns.
Subsequent rules, including the 2014 Voluntary Edition Proposed Rule (79 FR 10880) and the 2015 Edition Proposed Rule (80 FR 16804), explored but did not finalize imaging enhancements. The 2015 Edition Final Rule (80 FR 62602) eliminated the image results criterion after related program objectives were dropped. More recently, the 2024 HTI-2 Proposed Rule (89 FR 63498) suggested adding imaging links to criteria like VDT, but these were withdrawn in December 2025 (90 FR 60602). A 2025 joint RFI with the Centers for Medicare & Medicaid Services (CMS) (90 FR 21034) revealed ongoing issues, such as fragmented ecosystems and lack of API-driven patient access.
Key players include ONC, which oversees the voluntary Health IT Certification Program, and HHS Secretary Robert F. Kennedy, Jr., who signed the RFI. The program certifies health IT based on adopted standards, supporting programs like Medicare's Promoting Interoperability. Past decisions reflect a balance between interoperability goals and burdens on developers, as commenters in 2012 highlighted DICOM's complexity.
Solicitation of Comments: Transition to Electronic Methods
The RFI solicits feedback in two main areas. First, it addresses shifting from physical media to electronic access. Questions probe barriers patients face, such as inadequate internet in rural areas, and examples of successful electronic sharing outside networks. It asks about policies limiting exchange, including compliance concerns, state laws, or malpractice risks, and technical issues like system compatibility or image provenance.
The document emphasizes how the status quo burdens providers, potentially leading to delayed treatments or duplicative tests. For example, it notes that in time-sensitive cases, lack of prior images from external facilities can result in inappropriate care. Perspectives vary: providers may favor full-resolution DICOM files for specialties like radiology, while others might suffice with reference images like JPEGs. The RFI also questions the need for quantitative parameters derived from images, which are sometimes manually entered into EHRs due to standards gaps.
Solicitation of Comments: Standards and Certification
The second area focuses on standards and certified health IT. It inquires about current methods, such as DICOMweb, FHIR, or proprietary integrations, and metadata used in exchanges, including AI-added details. Barriers like ambiguous standards or custom interfaces are highlighted, with survey data cited on pediatric hospitals' reliance on CDs due to interoperability lacks (referencing a 2022 study in Pediatric Radiology).
The RFI explores updating the Certification Program, perhaps by adding image access to VDT or including elements in the United States Core Data for Interoperability (USCDI). It considers certifying PACS and VNAs directly and adopting standards like SMART Imaging Access for privacy concerns. Questions address unique privacy issues with images and focus on use cases like ocular imaging.
Implications and Perspectives
Short-term, responses could lead to targeted rulemaking, enhancing existing criteria without overburdening developers. Long-term, standards adoption might standardize exchanges, reducing silos and supporting value-based care models. Providers and patients could benefit from API access, but challenges include costs for small practices and ensuring equity in underserved areas.
Different views emerge: health IT developers may resist mandatory standards due to implementation burdens, as seen in past comments. Patient advocates push for direct access via apps, while clinicians emphasize diagnostic-quality images for accurate decisions. Policymakers weigh federal incentives against state variations. No single perspective dominates, but the RFI underscores a consensus on moving beyond physical media.
In summary, this RFI represents a renewed push for interoperability in diagnostic imaging, informed by historical regulatory efforts and current challenges. Potential next steps include analyzing comments to propose rules, possibly integrating standards like DICOM into certification. Ongoing debates center on balancing innovation with feasibility, addressing privacy in electronic exchanges, and ensuring equitable access. Future challenges may involve aligning with emerging technologies like AI, while monitoring impacts on care costs and outcomes.
